A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage

NCT01475474 | Completed Results

• 1 other identifier: Renew Medical - 210CLD
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.

Conditions

Bowel Incontinence

Keywords

incontinence; bowel; movement; fecal; anal; diarrhea; stool; rectal; feces; uncontrolled; loose; leakage; rectum; BM; watery; urgent; flatulence; gas

Outcome Measures

Primary Outcomes (2)

• Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings.

  This co-primary effectiveness endpoint was calculated as a relative percentage of the baseline Accidental Bowel Leakage (ABL) using the following equation: % reduction in ABL = 100\*(baseline period ABL - treatment period ABL) / (baseline period ABL)

  Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).

• Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores.

  The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20. This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner).

  Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16).

Interventions

Renew Insert DEVICE

The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Minimum Wexner Bowel incontinence score of 12 AND at least weekly (score of 3 or higher) leakage of solid and/or liquid type stool, with no greater than 50% of subjects with daily (score 4) of uncontrolled gas.
• Patients colon surveillance must be in compliance with American Cancer Society colon screening guidelines. If patient is out of compliance, they may be scheduled for Colonoscopy.
• Patient comprehends study meaning \& is capable of carrying out study duties
• Fluent in English

You may not qualify if:

• American Society of Anesthesiologist (ASA) score of 4 or higher
• Spinal cord injury or other major neurological diagnosis
• Known immune deficiency state
• Significant cardiac arrhythmia
• Pregnant or Breastfeeding
• Inflammatory bowel disease
• Requirement of medication delivered by suppository
• Active perianal abscess or fistula
• Present rectal prolapse
• Third degree hemorrhoids
• Anal stricture
• History or rectal spasm
• Rectal surgery in past 6 months
• Unresolved Anismus
• Fecal impaction with overflow diarrhea

Sponsors & Collaborators

• Renew Medical: lead

Study Sites (3)

Dr. Segall

Los Gatos, California, 95032, United States

Location

UCSD Medical Center

San Diego, California, 92103-8897, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (1)

• Lukacz ES, Segall MM, Wexner SD. Evaluation of an Anal Insert Device for the Conservative Management of Fecal Incontinence. Dis Colon Rectum. 2015 Sep;58(9):892-8. doi: 10.1097/DCR.0000000000000427.

  PMID: 26252852 DERIVED

MeSH Terms

Conditions

Fecal Incontinence; Diarrhea; Flatulence; Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Victoria Mackinnon, Vice President, Regulatory, Clinical & Quality
• Organization: Renew Medical, Inc.

victoria@renew-medical.com

1-888-987-2929

Study Officials

• Steven D Wexner, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

• Emily Lukacz, MD

  University of California, San Diego, CA

  PRINCIPAL INVESTIGATOR

• Mark Segall, MD

  The medical office of Mark Segall MD

  PRINCIPAL INVESTIGATOR

• Eric G Weiss, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 21, 2011
• Study Start: December 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 28, 2013
• Results First Posted: November 28, 2013

Record last verified: 2013-09

Locations

US (3)